Developmental toxicity evaluation of berberine in rats and mice

Area of Science:

• Toxicology
• Pharmacology
• Reproductive Science

Background:

• Berberine, a plant alkaloid, is present in herbal teas and supplements like goldenseal.
• Berberine chloride dihydrate (BCD) is a compound that has been evaluated for its toxicological profile.

Purpose of the Study:

• To assess the developmental toxicity of Berberine chloride dihydrate (BCD) in Sprague-Dawley rats and Swiss Albino mice.
• To determine the maternal and developmental toxicity levels of BCD in two distinct animal models.

Main Methods:

• Timed-mated rats and mice were administered BCD via feed across various dose levels during critical gestational periods.
• Dose levels were translated into mg/kg/day to establish exposure metrics for both species.
• A supplementary gavage study was conducted at 1,000 mg/kg/day due to feed scattering issues in high-dose groups.

Main Results:

• In rats, maternal weight gain was reduced at 7,250 ppm, and fetal body weight per litter was reduced at 14,500 ppm.
• In mice, equivocal maternal and developmental toxicity were observed at 5,250 ppm.
• The gavage study in rats indicated maternal toxicity but no developmental toxicity at 1,000 mg/kg/day.

Conclusions:

• In rats, the maternal toxicity LOAEL was confirmed at 7,250 ppm, with a developmental toxicity NOAEL of 1,000 mg/kg/day established via gavage.
• In mice, maternal toxicity LOAEL was 5,250 ppm, and developmental toxicity LOAEL was 1,000 mg/kg/day, with significant maternal mortality observed.
• BCD exhibits species-specific toxicity profiles, with higher risks observed in mice compared to rats.